Implantable bioabsorbable article

Abstract

An implantable bioabsorbable article for the separation and regeneration of tissue at a tissue defect site in the form of a fibrous matrix laminarly affixed to both surfaces of a cell-barrier sheet material. When implanted it allows ingrowth of tissue into the fibrous matrix side of the material; simultaneously the tissue to be regenerated at the tissue defect site is separated from the ingrowing tissue by the cell-barrier sheet material. A method for making the implantable bioabsorbable article is also described.

I claim: 
     
       1. A bioabsorbable article useful for the separation and regeneration of tissue comprising: a) a bioabsorbable, pliable, not brittle, cell-barrier polymeric sheet material being defined by a length, a width, and a thickness wherein the thickness has the smallest dimension, and wherein surfaces bounded by the length and width define first and second opposing surfaces, said first and second opposing surfaces being separated by the thickness of the sheet material;   b) a bioabsorbable fibrous matrix laminarly affixed to the first opposing surface of said bioabsorbable cell-barrier sheet material to cover at least a portion of the first opposing surface; and   c) a bioabsorbable fibrous matrix laminarly affixed to the second opposing surface of said bioabsorbable cell-barrier sheet material to cover at least a portion of the second opposing surface.   
     
     
       2. The article of claim 1 wherein both the cell-barrier sheet material and the fibrous matrix are comprised of a synthetic bioabsorbable material selected from the group consisting of polylactic acid, polyglycolic acid, poly-P-dioxanone, trimethylene carbonate, polycaprolactone and copolymers thereof. 
     
     
       3. The article of claim 2 wherein both the cell-barrier sheet material and the fibrous matrix are comprised of a copolymer of polylactic acid and polyglycolic acid. 
     
     
       4. The article of claim 2 wherein the cell-barrier sheet material is comprised of a copolymer of polylactic acid and polyglycolic acid and the fibrous matrix is comprised of polyglycolic acid fibers. 
     
     
       5. The article of claim 4 wherein the cell-barrier sheet material is comprised of a copolymer of about 50% polylactic acid and 50% polyglycolic acid. 
     
     
       6. The article of claim 4 wherein the cell-barrier sheet material is comprised of a copolymer of about 65% polylactic acid and 35% polyglycolic acid. 
     
     
       7. The article of claim 4 wherein the cell-barrier sheet material is comprised of a copolymer of about 85% polylactic acid and 15% polyglycolic acid. 
     
     
       8. The article of claim 1 wherein the fibrous matrix comprises a mesh of fibers in a random, unorganized configuration. 
     
     
       9. The article of claim 1 wherein the bioabsorbable fibrous matrix comprises a mesh of fibers in an organized configuration selected from the group consisting of threads, yarns, nets, knits, weaves, laces and felts. 
     
     
       10. The article of claim 1 wherein the cell-barrier sheet material is porous having a pore size small enough to substantially preclude the passage and ingrowth of tissue. 
     
     
       11. The article of claim 1 incorporating a suture affixed to the bioabsorbable article. 
     
     
       12. The article of claim 1 wherein at least a portion of the article is impregnated with a substance selected from the group consisting of antibiotics, antimicrobials, growth factors, differentiation factors and cell attachment factors. 
     
     
       13. A bioabsorbable article for promoting tissue regeneration, comprising a length of pliable, not brittle, bioabsorbable material having a first outer surface adapted for supporting tissue ingrowth, a second outer surface opposed to the first outer surface and adapted for supporting tissue ingrowth, the first and second outer surfaces each extending substantially the length of the bioabsorbable material, and a polymeric barrier between the first and second surfaces and extending substantially the length of the bioabsorbable material, the barrier adapted to substantially prevent tissue migration between the first and second outer surfaces. 
     
     
       14. The article of claim 13, wherein the length of bioabsorbable material is substantially planar in shape. 
     
     
       15. The article of claim 13, further comprising a suture attached to the length of bioabsorbable material. 
     
     
       16. A multi-layered bioabsorbable article for promoting tissue regeneration, comprising a pliable, not brittle, substantially cell-impermeable polymeric inner layer defined by a length, a width, and a thickness wherein the thickness has the smallest dimension, and wherein surfaces bounded by the length and width define first and second opposing surfaces, a first cell-permeable outer layer superposed on a first surface of the inner layer, and a second cell-permeable outer layer superposed on a second surface of the inner layer opposite the first surface so that the inner layer is positioned between and separates the first and second outer layers. 
     
     
       17. The article of claim 16, wherein the article is substantially planar in shape. 
     
     
       18. The article of claim 16, further comprising a suture attached to the article. 
     
     
       19. A bioabsorbable article useful for the separation and regeneration of tissue comprising: a) a bioabsorbable, pliable, not brittle, cell-barrier sheet material being defined by a length, a width, and a thickness wherein the thickness has the smallest dimension, and wherein surfaces bounded by the length and width define first and second opposing surfaces, said first opposing surface being in a first plane and said second opposing surface being in a second plane, said planes being separated by the thickness of the sheet material;   b) a bioabsorbable fibrous matrix laminarly affixed to the first opposing surface of said bioabsorbable cell-barrier sheet material to cover at least a portion of the first opposing surface; and   c) a bioabsorbable fibrous matrix laminarly affixed to the second opposing surface of said bioabsorbable cell-barrier sheet material to cover at least a portion of the second opposing surface.   
     
     
       20. A bioabsorbable article for promoting tissue regeneration, comprising a length of pliable, not brittle, bioabsorbable material having a first outer surface adapted for supporting tissue ingrowth, a second outer surface opposed to the first outer surface and adapted for supporting tissue ingrowth, the first and second outer surfaces each extending substantially the length of the bioabsorbable material, and a cell barrier between the first and second surfaces and extending substantially the length of the bioabsorbable material, the barrier adapted to substantially prevent tissue migration between the first and second outer surfaces. 
     
     
       21. A multi-layered bioabsorbable article for promoting tissue regeneration, comprising a pliable, not brittle, substantially cell-impermeable inner layer defined by a length, a width, and a thickness wherein the thickness has the smallest dimension, and wherein surfaces bounded by the length and width define first and second opposing surfaces, a first cell-permeable outer layer superposed on a first surface of the inner layer, and a second cell-permeable outer layer superposed on a second surface of the inner layer opposite the first surface so that the inner layer is positioned between and separates the first and second outer layers.